BEUDAMED
    FDA Registration Active 🇺🇸 United States

    01-00XX Series, Drape

    Reg #: 1717344 · FEI: 1717344 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Covidien
    Registration Number
    1717344
    FEI Number
    1717344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6044 Longbow Court
    City
    BOULDER
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041501

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    Cover, Barrier, Protective MMP

    Proprietary Names

    01-00XX Series, Drape Situate™ Sterile Drape, 01-0020 Situate™ Sterile Drape, 01-0037 Situate™ Non-Sterile Drape, 01-0026

    Establishment Types

    Repack or Relabel Medical Device